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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.
President Obama recently announced in his State of the Union address that he plans to allocate $215 million in the 2016 budget for a Precision Medicine Initiative, and this money will go to the National Institutes of Health (NIH), the National Cancer Institute, the Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA). Part of President Obama’s plan for a comprehensive plan includes a push to compile a national database full of genomic sequencing data.
In the White House fact sheet on the plan, FDA is tasked with developing a new approach for evaluating Next Generation Sequencing (NGS) technologies. The agency will receive $10 million for hiring experts to help evaluate tests based on sequencing large parts of a patient’s genome, to help build databases of disease mutations, and possibly, decide whether or not to revamp its personalized therapy regulatory process. Margaret Hamburg wrote on the FDA blog that the agency “intends to develop a practical and nimble approach that will allow medical advances to be implemented as soon as possible, using its regulatory flexibility and the power of the information placed into high-quality databases."
FDA’s effort to gather patient data privately and evaluate NGS technologies for accuracy and reliability is fodder for public discussion, Hamburg stressed, and will therefore be the topic of public meeting on Feb. 20, 2015.
Although many pharmaceutical companies may welcome the news that more data will be available to access, some also worry that the increased volume of data may not easily be digested in a usable way. Vertex’s CEO Jeffrey Leiden told Bloomberg that there may be an issue in terms of the practicality of the data collection across platforms. “When you put multiple databases together, you need to make sure that the components are the same, that you’re using the same definitions, the same phenotyping."